Overview

The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and the tolerance of the coadministration of zidovudine and ddI or ddC.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Glaxo Wellcome
Treatments:
Antiviral Agents
Didanosine
Zalcitabine
Zidovudine
Criteria
Inclusion Criteria

Concurrent Medication:

Allowed:

- Patients with PCP may be randomized to study medication after contacting the sponsor
and following a minimum 7-day course of therapy resulting in stabilization of their
disease. Patients with stabilized disease must have fever < 39 C for at least 48
hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm.

- Prophylaxis for PCP.

Patients must have the following:

- HIV-1 seropositive by any federally licensed ELISA.

- Willingness to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Any immediately life-threatening infection or medical condition present at time of
study entry.

- Any active opportunistic infection requiring chronic therapy with any of the agents
listed in the exclusion concurrent medication section.

- Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.

- Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic
chemotherapy.

- AIDS dementia complex, > or = Stage 2.

- History of zidovudine induced toxicity.

- Prior history of acute pancreatitis during the past two years or chronic pancreatitis.

- Grade 2 neuropathy.

- Intractable diarrhea.

- History of seizures within the past six months or current requirement of
anticonvulsants.

- Past or current heart disease.

- Fever > 39 C at entry.

Concurrent Medication:

Current requirement of anticonvulsants.

- Excluded:

- It is intended that patients developing new opportunistic infections during the course
of the study will continue study participation, unless required therapy is associated
with significant neurologic or hematologic toxicities, in which case the study
medication may be temporarily discontinued.

- Ganciclovir.

- Chloramphenicol.

- Cisplatinum.

- Iodoquinol.

- Systemic Pentamidine.

- Disulfiram.

- Ethionamide.

- Glutethimide.

- Gold.

- Hydralazine.

- Metronidazole.

- Sodium Cyanate.

- Thalidomide.

- Vincristine.

- Allopurinol.

- Probenecid.

Concurrent Treatment:

Excluded:

- Radiation therapy. (with the exception of electron beam therapy to an area of <
100cm/m2.)

Patients with the following are excluded:

- Any immediately life-threatening infection or medical condition present at time of
study entry.

- Any active opportunistic infection requiring chronic therapy with any of the agents
listed in the exclusion concurrent medication section.

- Active alcohol or drug abuse, sufficient in the investigator's opinion to prevent
compliance with study therapy.

- Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.

- Kaposi's syndrome with visceral involvement or requiring systemic cytotoxic
chemotherapy.

- AIDS dementia complex, > or = Stage 2.

- History of zidovudine induced toxicity.

- Any experimental therapy within 30 days.

- Prior history of acute pancreatitis during the past two years or chronic pancreatitis.

- Grade 2 neuropathy.

- Intractable diarrhea.

- History of seizures within the past six months or current requirement of
anticonvulsants.

- History of past or current heart disease.

- Fever > 39 C at entry.

Prior Medication:

Excluded:

- Any anti-HIV therapy (other than zidovudine), biologic response modifiers, or
pharmacologic doses of corticosteroids within eight weeks of entry (except for the
management of severe PCP, in which case duration is not to exceed 21 days).

- Zidovudine therapy for greater than four weeks or prior discontinuation due to drug
toxicity.

- Prior therapy with ddI, ddC, D4T, or interferon.

- Any experimental therapy within 30 days.

- Therapy within 30 days with neurotoxic drugs.

Prior Treatment:

Excluded:

- Radiation therapy within two weeks of entry or likely to require radiation therapy
(with the exception of electron beam therapy to an area of < 100cm/m2).

Active alcohol or drug abuse, sufficient in the investigator's opinion, to prevent
compliance with study therapy.